MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA DVE/MOVITA; MEDICAL GAS AND VACUUM SYSTEMS

Catalog Number G16707

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that in the early morning, during the operating room preparation, while the operator move down the perseus attached on movita ls strong, the anesthetic device fall down from its movita support and the operator accompanied it to the floor.No injury to a patient or staff was reported.

Event Description

It was reported that in the early morning, during the operating room preparation, while the operator move down the perseus attached on movita ls strong, the anesthetic device fall down from its movita support and the operator accompanied it to the floor.No injury to a patient or staff was reported.

Manufacturer Narrative

The investigation was based on the reported event and enhanced information like email correspondence and photos from the affected ceiling supply unit movita.It has been reported that due to accidentally placing the anesthesia machine on a surgical stool while lowering the supply unit, a perseus anesthesia machine became disconnected and fell to the floor.No persons were injured at the event, no health consequences were reported.It was found that the dip switches on the circuit board for this version of the supply unit with device holder and lift function were not set correctly.The dip switches on the circuit board are set at the factory.In case of replacement in the field, a repair and test instruction describe the settings.The switch key on the affected movita for perseus operation was set correctly and the key was not in the lock as required by the ifu.The unit support on the supply unit was set too low.The deviations could be corrected by a service technician on site according to the manufacturer's specifications.The ifu for movita describes being aware of obstacles when moving the supply unit.For the perseus version, a switch key is provided as a safeguard so that only service personnel can perform the undocking and docking procedure.The accompanying repair and test manual describe how to replace the circuit board and other parts and what tests should be performed after the repair.As no similar complaints were found in database this is handled as a single event without systematic failure.The number of similar cases, related to the same root cause, is therefore within the expected range of the respective risk assessment and thus accepted.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that in the early morning, during the operating room preparation, while the operator move down the perseus attached on movita ls strong, the anesthetic device fall down from its movita support and the operator accompanied it to the floor.No injury to a patient or staff was reported.

• Brand Name: DVE/MOVITA
• Type of Device: MEDICAL GAS AND VACUUM SYSTEMS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11955414
• MDR Text Key: 261699136
• Report Number: 9611500-2021-00243
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• PMA/PMN Number: D167937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G16707
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1